Quality System Specialist

McKesson Corporation; Richmond (VA); Hybrid; USD 83,300 - 138,800; Full time

Job summary

McKesson Corporation is seeking an eQMS System Administrator to configure, validate, and administer the electronic Quality Management System. You will partner with Quality, Regulatory, IT, and stakeholders to develop workflows for Complaints, CAPA, Change Control, Training, Document Control, Audits, and Risk Management, while owning quality system reporting.

You will ensure regulatory alignment, data integrity, and audit readiness, supporting continuous improvement and cross-functional

Qualifications

• Minimum 4-6 years of experience in Quality Systems or regulated systems administration.
• Hands-on experience administering and validating an eQMS in a regulated industry.
• Experience developing workflows and reporting for multiple quality system processes.
• Bachelor's degree in science, engineering, information systems, or a related field.

Responsibilities

• Serve as the eQMS System Administrator and Business Process Owner for quality system workflows.
• Configure, maintain, and optimize eQMS modules, workflows, forms, user roles, and permissions.
• Ensure system configuration aligns with approved SOPs, regulatory expectations, and data integrity principles.
• Act as primary liaison between Quality and IT for eQMS-related issues, enhancements, and upgrades.
• Support system access management, periodic access reviews, and audit readiness activities.
• Develop, configure, and maintain validated eQMS workflows, including Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, Risk Management.
• Author and execute system validation documentation (e.g., URS, FRS, IQ/OQ/PQ, validation summaries).
• Assess impact of system changes and support change control activities related to the eQMS.
• Ensure workflows support traceability, escalation, approvals, and regulatory reporting requirements.
• Design, develop, and maintain QMS reports, KPIs, and dashboards to support Management Review, quality performance monitoring, trending and risk identification.
• Track and trend quality system metrics (e.g., CAPA aging, complaint trends, training compliance, audit findings).
• Analyze data to identify systemic issues and continuous improvement opportunities.
• Present quality system performance data to Quality leadership and crossfunctional stakeholders.
• Provide general quality systems SME support (e.g., Document Control, CAPA, Supplier Quality, Validation, Change Control, etc.).
• Ensure procedures and document workflows comply with document control SOPs and regulatory expectations.
• Support QMS training programs, including role-based training assignments and effectiveness tracking.
• Provide end‑user support and troubleshooting related to eQMS workflows and reporting.
• Support internal, customer, and regulatory audits by providing eQMS records, reports, and system evidence.
• Ensure eQMS configuration supports compliance with applicable regulations and standards (e.g., FDA, ISO).
• Participate in inspection readiness activities related to electronic records and data integrity.
• Support continuous improvement of quality system processes and system usability.

Skills

Analytical skills

Data visualization

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in science/engineering/information systems

Tools

eQMS platforms

MS Office

Job description

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care.

What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you.

EQMS System Administrator

The eQMS System Administrator is responsible for the configuration, validation, and ongoing administration of the electronic Quality Management System (eQMS). This role serves as the technical and process owner for quality system workflows, ensuring they are compliant, validated, userfriendly, and aligned with regulatory requirements and business needs.

The eQMS System Administrator partners closely with Quality, Regulatory, IT, and crossfunctional stakeholders to develop and maintain workflows for Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, and Risk Management. This role also owns quality system reporting, KPIs, and dashboards to support Management Review and continuous improvement initiatives.

Key Responsibilities

• Serve as the eQMS System Administrator and Business Process Owner for quality system workflows.
• Configure, maintain, and optimize eQMS modules, workflows, forms, user roles, and permissions.
• Ensure system configuration aligns with approved SOPs, regulatory expectations, and data integrity principles.
• Act as primary liaison between Quality and IT for eQMS-related issues, enhancements, and upgrades.
• Support system access management, periodic access reviews, and audit readiness activities.

Workflow Development & Validation

• Develop, configure, and maintain validated eQMS workflows, including Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, Risk Management.
• Author and execute system validation documentation (e.g., URS, FRS, IQ/OQ/PQ, validation summaries).
• Assess impact of system changes and support change control activities related to the eQMS.
• Ensure workflows support traceability, escalation, approvals, and regulatory reporting requirements.

Reporting, Metrics & Dashboards

• Design, develop, and maintain QMS reports, KPIs, and dashboards to support Management Review, quality performance monitoring, trending and risk identification.
• Track and trend quality system metrics (e.g., CAPA aging, complaint trends, training compliance, audit findings).
• Analyze data to identify systemic issues and continuous improvement opportunities.
• Present quality system performance data to Quality leadership and crossfunctional stakeholders.

SME Support General Quality Systems

• Provide general quality systems SME support (e.g., Document Control, CAPA, Supplier Quality, Validation, Change Control, etc.).
• Ensure procedures and document workflows comply with document control SOPs and regulatory expectations.
• Support QMS training programs, including role-based training assignments and effectiveness tracking.
• Provide end‑user support and troubleshooting related to eQMS workflows and reporting.

Audit & Compliance Support

• Support internal, customer, and regulatory audits by providing eQMS records, reports, and system evidence.
• Ensure eQMS configuration supports compliance with applicable regulations and standards (e.g., FDA, ISO).
• Participate in inspection readiness activities related to electronic records and data integrity.
• Support continuous improvement of quality system processes and system usability.

Additional Responsibilities

The above statements describe the general nature and level of work being performed. Additional responsibilities may be assigned as required.

Experience Required

• Minimum 4-6 years of experience in Quality Systems, Quality Assurance, or regulated systems administration.
• Hands‑on experience administering and validating an eQMS in a regulated industry (medical device, pharmaceutical, or combination products).
• Experience developing workflows and reporting for multiple quality system processes.

Education

Bachelor's degree in science, engineering, information systems, or a related field.

Specialized Knowledge/Skills

• Strong understanding of regulated quality systems and electronic records requirements.
• Working knowledge of FDA regulations (e.g., 21 CFR 210, 211, 820, 803, 806, Part 11) and ISO standards (e.g., ISO 13485, ISO 14971).
• Experience with system validation and change control.
• Strong analytical, reporting, and data visualization skills.Excellent written and verbal communication skills.
• High attention to detail with strong organizational and planning skills.
• Ability to work cross‑functionally and manage multiple priorities.

PC/Equipment

• Proficient in MS Office or the Google Platform
• Experience with eQMS platforms and reporting tools.

Work Environment/Physical Demands

• General office or remote work environment.
• Availability to support audits and system activities during U.S. business hours.
• Limited travel may be required.

Base Pay Range

$83,300 - $138,800

Equal Employment Opportunity

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) [e-mail] or (Canada) [e-mail]. Resumes or CVs submitted to this email box will not be accepted.